Sr. Quality Systems Specialist, Quality Operational Readiness (QOR)

GRIFOLS, S.A.•NC-Clayton, CA

1d•Onsite

About The Position

The Global Quality Operational Readiness (QOR) Sr. Quality Systems Specialist supports implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities and new processes or facilities at existing sites across the EU, US, Canada, and other global locations. The role helps ensure new sites meet global regulatory requirements and internal quality standards from the outset. Working within cross-functional quality teams and with subject matter experts, the specialist collaborates with Engineering, Manufacturing, Regulatory Affairs, IT, site Quality, and Global Quality to establish robust quality systems and processes aligned with cGMP and global health authority expectations. The position requires independent work with limited supervision in evolving project environments. The specialist translates direction and stakeholder requirements into action, advances deliverables amid changing priorities, identifies solutions, manages multiple priorities, and builds stakeholder alignment through collaboration, influence, and credibility. The role includes travel to supported Biopharma sites, including international travel. Work is performed in an office environment, with frequent visits to production plants and GMP areas for walkthroughs and compliance and improvement activities.

Requirements

PhD in Life Sciences, Chemical Sciences, or a relevant degree (STEM preferred) and at least 4 years of relevant experience; or a master's degree in these fields and at least 6 years of relevant experience; or a bachelor's degree in these fields and at least 7 years of relevant experience; or an equivalent combination of education and experience.
Knowledge of regulatory requirements, including those of the U.S. FDA, EMA, and Health Canada.
Ability to analyze data and metrics to inform decisions and identify improvement opportunities.
Effective communication skills, including communicating technical and non-technical concepts to diverse stakeholders, asking effective questions, incorporating feedback, and adapting communication style.
Ability to execute independently, own deliverables, and advance work in dynamic environments.
Ability to identify, assess, and mitigate product quality and compliance risks.
Ability to identify quality issues quickly and recommend effective solutions.
Ability to collaborate across departments and with external partners to achieve alignment and quality.
Project management skills to monitor multiple initiatives, ensure timely completion, and report progress frequently to management.
Ability to rapidly absorb, retain, and apply new information, concepts, processes, and business requirements across multiple disciplines.
Ability to travel 15% to 50% to supported Biopharma sites, including international travel.
Ability to communicate and understand spoken and written information, interact with others, relate sensitive information to diverse groups, and work with diverse groups to obtain consensus.

Responsibilities

Facilitate transfer of knowledge and best practices from established Grifols sites, identifying and implementing efficient, inspection-tested, cGMP-compliant practices aligned with current regulatory expectations.
Collaborate with Engineering, Manufacturing, Regulatory Affairs, IT, and other teams to embed quality in new-site design and startup operations.
Translate strategic objectives and stakeholder requirements into practical deliverables, recommendations, and implementation plans with minimal management oversight.
Independently execute Operational Readiness deliverables, taking ownership and progressing work while escalating risks, barriers, and recommended solutions appropriately.
Monitor project timelines, quality milestones, and risk mitigation plans, and routinely make KPIs visible to stakeholders and senior management.
Plan for regulatory inspection readiness through mock audits, gap assessments, and practice sessions with site personnel.
Assist startup sites with review of validation master plans, sampling plans, master data setup, site master files, and product and raw material specifications.
Recommend improvement opportunities to site Quality and Global Quality using sound judgment and expertise.
Help BioPharma sites solve problems, mitigate quality risks, and improve processes using risk-based quality approaches.
Build and maintain effective working relationships across Manufacturing, Quality, Validation, Engineering, Regulatory Affairs, and Global Quality through collaboration, active listening, and influence-based leadership.
Monitor timelines and maintain urgency with site Quality contacts so quality support does not adversely affect project milestones, while ensuring competent quality oversight of new-site processes.
Visit production plants and conduct walkthroughs in manufacturing, warehouse, and other GMP areas to identify improvement opportunities and partner with site management to implement improvements.
Proactively identify quality solutions and establish robust, appropriately mapped quality systems for effective operations and external regulatory review.
Work with QOR and BioPharma site subject matter experts to drive and monitor continuous improvement and operational preparedness activities.
May serve as a manager delegate, as applicable and with demonstrated experience.